A study of add-on rTMS on craving in patients with opioid dependence
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To compare the craving experienced by patients with opioid dependence receiving antagonist treatment with add-on rTMS with those receiving antagonist treatment alone.
研究概览
简要总结
Repetitive Transcranial Magnetic Stimulation rTMS over the Prefrontal cortex PFC has a regulatory effect on mesolimbic and mesostriatal dopaminergic pathways We aim to study the effect of add-on rTMS on craving in patients with opioid dependence This is an interventional, single-blind randomised controlled study. The withdrawal symptoms of the patients will be managed and those with Clinical Opioid Withdrawal Scale COWS <5 and off benzodiazepines for 24 hrs will be included in this study. 48 patients will be recruited and randomly allocated in active and sham rTMS groups. TMS screening checklist will be applied for the eligibility of the participants. These patients will receive 2 sessions of rTMS over left DLPFC at a gap of 15 minutes for 5 days. Patients will be assessed at baseline, 1st, 2nd and 4th week. Craving will be assessed using Bried substance craving scale (BSCS) and Visual analog scale (VAS). Subjective well-being will be assessed using the WHO-5 well-being index. rTMS side-effect checklist and UKU side-effect checklist will be applied to monitor side effects. There are no risks as all necessary precautions will be taken. There are no known serious side effects of the intervention. Mild side effects include headache, muscle stiffness, scalp irritation, nausea, dizziness, fatigue/lightheadedness, and dry mouth. These side effects are temporary and may resolve on their own or with minimal medical care. There are no known long-term side effects of the intervention. After data collection, the data will be properly recorded in MS Excel following which it will be coded/recoded to an SPSS supported format. The data will then be transferred to SPSS v. 24 (IBM SPSS) for analysis. Association and correlation between the parameters shall be drawn using various analysis methods (such as student T-test, ANOVA, chi-square test, etc.) Proper conclusions will be drawn from the result of the analysis. We expect that rTMS will help reduce craving in patients and subsequently prevent opioid use among patients. While compared to standard forms of treatment, this study may help patients achieve improvement in their craving way earlier. This will significantly improve the quality of life of these patients. In the future, it can be used for the betterment of society.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of opioid dependence as per International Classification of Diseases 11th Revision ICD 11 Complete abstinence from opioids for at least 5 days Clinical Opioid Withdrawal Scale COWS score of less than 5 Informed written consent from the patient.
排除标准
- •A current diagnosis of any other psychiatric disorder except nicotine dependence and personality disorders Any significant medical comorbidity requiring priority management Not eligible to receive rTMS according to TMS screening checklist Any patient who doesnt have the mental ability to comprehend the consent form.
结局指标
主要结局
To compare the craving experienced by patients with opioid dependence receiving antagonist treatment with add-on rTMS with those receiving antagonist treatment alone.
时间窗: Baseline | 1 week | 2 week | 4 week
次要结局
- To compare the opioid use rates among patients with opioid dependence receiving antagonist treatment with add-on rTMS with those receiving antagonist treatment alone.(Baseline)
- To compare the subjective well-being of patients with opioid dependance receiving antagonist treatment with add-on rTMS with those receiving antagonist treatment alone.(Baseline)
研究者
Dr Sanjana Bhasin
King George Medical University